A simpler, easier and safer single-use TFF solution for R&D, clinical or commercial manufacturing
Cadence single-use tangential flow filtration (TFF) modules are ready-to-use gamma irradiated cassette modules designed for single-use in Pall Allegro™ single-use TFF systems and can also be integrated into other single-use TFF set-ups. They provide ease-of-use, quick turnaround and increased flexibility, safety and containment in cGMP operations.
Cadence single-use TFF modules can be easily implemented in single-use TFF systems for concentration and diafiltration steps from R&D to commercial production of biotech products or vaccines.
Simpler and easier solutions: preassembled, ready-to-use modules for easy integration into single-use TFF systems.
Safer solutions: single-use, gamma irradiated, contained modules for product and operator safety.
Cadence single-use TFF modules are delivered as preassembled modules that have been gamma irradiated at ≥ 25 kGy
Ease of installation and integration in single-use TFF systems
Supplied preconditioned, stored in water and gamma irradiated, the modules do not require comprehensive conditioning steps prior to use (see schematic 1). Typically less than 20 L/m² flush volumes are required to reach TOC levels below 1 ppm.
Improved productivity, reducing downtime and allowing focus on product processing operations only
No chemical handling
Reduction of buffer or WFI consumption
Designed for fully single-use operation, Cadence single-use TFF modules can provide post-use containment during the single-use fluid flow path disassembly.
Increased process, product and operator safety
No cross contamination
Post-use containment of hazardous product
Cadence single-use TFF modules integrate the process-proven Omega PES membrane and are scalable.
Scalable formats, streamlining product development and process optimization
Tests have shown that the process performances of the Cadence single-use TFF modules are comparable to reusable Omega T-series cassettes, thus offering the flexibility to switch from single-use to reuse TFF options and vice-versa with limited validation work.
Improved process robustness
Improved process robustness
Schematic 1: Comparison of TFF operations, reusable cassettes versus single-use with Cadence modules
Cadence single-use TFF modules are available in five formats with the following membrane areas:
They integrate process-proven Pall Omega polyethersulfone (PES) membranes to offer high flux and selectivities. The Omega membranes have been specifically modified to minimize protein binding.
Cadence single-use TFF modules are available with Omega membrane in three different nominal molecular weight cutoffs (NMWC) - 10 kD, 30 kD and 100 kD - meeting the majority of the needs for single-use TFF applications in the biotech and vaccines industries.
The single-use TFF modules can be installed and torqued into specially designed Cadence holders and operated with the Allegro single-use TFF systems or with other single-use set-ups.
Manufactured in a controlled environment
Manufactured under a quality management system certified to ISO 9001 standards
Supplied with a Certificate of Quality confirming the quality standards and quality control tests performed by Pall
The fluid path meets all regulatory requirements for:
Biological Reactivity Tests (in vivo) for Class VI-70°C Plastics, USP <88>
Biological Reactivity Tests (in vitro) for Cytotoxicity, USP <87>
Typical applications for Allegro single-use TFF solutions with Cadence single-use TFF modules are in the downstream processing operations for the concentration and/or diafiltration of biological products in the biotech and vaccines industries.
The Cadence single-use TFF modules can be implemented from R&D lab to commercial production. Fully scalable, the drug product development and validation steps can be streamlined.
Purpose-designed for single-use, they are especially recommended for multipurpose facilities or CMOs, for clinical material or for commercial production with batch sizes up to several hundred liters.